NCT05689736

Brief Summary

The CDC's Essentials for Parenting Toddlers and Preschoolers program (EFP) is a free Internet resource with the potential to break down barriers to population-wide access to scientifically-based parenting interventions. EFP has considerable promise, but parental engagement, a major issue in the success of universal parenting interventions, remains a challenge. The objective of the proposed research is to optimize EFP by identifying engagement-focused intervention elements to add to EFP that enhance its effects on parenting skills.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
859

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

September 16, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2024

Completed
Last Updated

July 31, 2025

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

December 19, 2022

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Parent Behavior Inventory, item average of Supportive/Engaged subscale

    Parental warmth (e.g., physical affection) will be measured by parent completing the 10-item self-report Supportive Engaged subscale of the Parent Behavior Inventory.

    6 months

  • Parent-Child Conflict Tactics Scale, item average of Corporal Punishment subscale

    Corporal punishment (noninjurious physical discipline, e.g., spanking) will be measured by parent completing the 6-item self-report corporal punishment subscale of the Parent-Child Conflict Tactics Scale

    6 months

  • Parenting Scale, item average of Overreactivity subscale

    Parents' use of harsh or otherwise overreactive discipline (i.e., angry discipline) will be measured by parent completing the 10-item self-report Overreactivity subscale of the Parenting Scale.

    6 months

  • Parenting Scale, item average of Laxness subscale

    Use of permissive or lax discipline (e.g., failure to enforce rules) will be measured by parent completing the 11-item self-report Laxness subscale of the Parenting Scale

    6 months

Study Arms (16)

Motivational Enhancements + Simplification + Gamification + Low Engagement Nudge

EXPERIMENTAL

Participants will receive the Core Essentials for Parenting (EFP) intervention and all additional engagement-focused intervention elements: motivational enhancements, simplification, gamification, and low engagement nudges.

Behavioral: Motivational EnhancementBehavioral: SimplificationBehavioral: GamificationBehavioral: Low Engagement NudgesBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Motivational Enhancements + Simplification + Gamification

EXPERIMENTAL

Participants will receive the Core EFP intervention and motivational enhancement, simplification, and gamification intervention elements.

Behavioral: Motivational EnhancementBehavioral: SimplificationBehavioral: GamificationBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Motivational Enhancements + Simplification + Low Engagement Nudge

EXPERIMENTAL

Participants will receive the Core EFP intervention and motivational enhancement, simplification, and low engagement nudges as intervention elements.

Behavioral: Motivational EnhancementBehavioral: SimplificationBehavioral: Low Engagement NudgesBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Motivational Enhancements + Simplification

EXPERIMENTAL

Participants will receive the Core EFP intervention and motivational enhancement and simplification as intervention elements.

Behavioral: Motivational EnhancementBehavioral: SimplificationBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Motivational Enhancements + Gamification + Low Engagement Nudge

EXPERIMENTAL

Participants will receive the Core EFP intervention and motivational enhancement, gamification, and low engagement nudge as intervention elements.

Behavioral: Motivational EnhancementBehavioral: GamificationBehavioral: Low Engagement NudgesBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Motivational Enhancements + Gamification

EXPERIMENTAL

Participants will receive the Core EFP intervention and motivational enhancement and gamification as intervention elements.

Behavioral: Motivational EnhancementBehavioral: GamificationBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Motivational Enhancements + Low Engagement Nudge

EXPERIMENTAL

Participants will receive the Core EFP intervention and motivational enhancement and low engagement nudge as intervention elements.

Behavioral: Motivational EnhancementBehavioral: Low Engagement NudgesBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Motivational Enhancements

EXPERIMENTAL

Participants will receive the Core EFP intervention and motivational enhancement as an additional intervention element.

Behavioral: Motivational EnhancementBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Simplification + Gamification + Low Engagement Nudge

EXPERIMENTAL

Participants will receive the Core EFP intervention and simplification, gamification, and low engagement nudge as additional intervention elements.

Behavioral: SimplificationBehavioral: GamificationBehavioral: Low Engagement NudgesBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Simplification + Gamification

EXPERIMENTAL

Participants will receive the Core EFP intervention and simplification and gamification as additional intervention elements.

Behavioral: SimplificationBehavioral: GamificationBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Simplification + Low Engagement Nudge

EXPERIMENTAL

Participants will receive the Core EFP intervention and simplification and low engagement nudge as intervention elements.

Behavioral: SimplificationBehavioral: Low Engagement NudgesBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Simplification

EXPERIMENTAL

Participants will receive the Core EFP intervention and simplification as an additional intervention element.

Behavioral: SimplificationBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Gamification + Low Engagement Nudge

EXPERIMENTAL

Participants will receive the Core EFP intervention and gamification and low engagement nudge as additional intervention elements.

Behavioral: GamificationBehavioral: Low Engagement NudgesBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Gamification

EXPERIMENTAL

Participants will view the Core EFP and will be exposed only to gamification as an additional intervention element.

Behavioral: GamificationBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Low Engagement Nudge

EXPERIMENTAL

Participants will receive the Core EFP intervention and low engagement nudge as an additional intervention element.

Behavioral: Low Engagement NudgesBehavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

EFP Only

EXPERIMENTAL

Participants will receive the Core EFP intervention and not be exposed to any additional intervention elements.

Behavioral: Essentials for Parenting Toddlers and Pre-schoolers (EFP)

Interventions

Motivational Enhancements (ME) will include three features: 1. Personalized change plan. Parents will describe their intervention goals, motivation for participation, steps they are willing to take to meet those goals, as well as potential barriers to engagement and strategies to try to overcome such barriers. We will display the change plan to remind parents of their personalized responses. ME will also integrate participants' change plan responses into intervention content. 2. Assessment feedback. We will provide norm-referenced feedback for each selected parenting measure after the week 1 assessment. For simplicity, feedback will graphically categorize the parent or child in 3 categories per outcome: red (≥90th %ile), yellow (70-89th %ile), and green (\<70th %ile). 3. Modified, personalized SMS text nudges. Parents will receive 2 weekly personalized SMS messages based on their change plan responses.

Motivational EnhancementsMotivational Enhancements + GamificationMotivational Enhancements + Gamification + Low Engagement NudgeMotivational Enhancements + Low Engagement NudgeMotivational Enhancements + SimplificationMotivational Enhancements + Simplification + GamificationMotivational Enhancements + Simplification + Gamification + Low Engagement NudgeMotivational Enhancements + Simplification + Low Engagement Nudge
SimplificationBEHAVIORAL

We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement.

Motivational Enhancements + SimplificationMotivational Enhancements + Simplification + GamificationMotivational Enhancements + Simplification + Gamification + Low Engagement NudgeMotivational Enhancements + Simplification + Low Engagement NudgeSimplificationSimplification + GamificationSimplification + Gamification + Low Engagement NudgeSimplification + Low Engagement Nudge
GamificationBEHAVIORAL

Gamification will include four features: 1. Game-like graphical environment (e.g., avatars to represent the participant). 2. Digital rewards. Parents will receive points and badges for completing intervention activities. 3. Leaderboard. A leaderboard will be used to activate competitive motives and social referencing. The leaderboard will display the points/badges of the participant relative to 4 other actual or simulated anonymized parents who are at a similar point in the intervention; their number of points and badges will be determined by those of the participant. 4. Modified, personalized SMS text nudges. SMS text nudges will alternate between Core content (e.g., reminder to complete a module) and reminders about game features such as badges and standings.

GamificationGamification + Low Engagement NudgeMotivational Enhancements + GamificationMotivational Enhancements + Gamification + Low Engagement NudgeMotivational Enhancements + Simplification + GamificationMotivational Enhancements + Simplification + Gamification + Low Engagement NudgeSimplification + GamificationSimplification + Gamification + Low Engagement Nudge

SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module.

Gamification + Low Engagement NudgeLow Engagement NudgeMotivational Enhancements + Gamification + Low Engagement NudgeMotivational Enhancements + Low Engagement NudgeMotivational Enhancements + Simplification + Gamification + Low Engagement NudgeMotivational Enhancements + Simplification + Low Engagement NudgeSimplification + Gamification + Low Engagement NudgeSimplification + Low Engagement Nudge

All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting.

EFP OnlyGamificationGamification + Low Engagement NudgeLow Engagement NudgeMotivational EnhancementsMotivational Enhancements + GamificationMotivational Enhancements + Gamification + Low Engagement NudgeMotivational Enhancements + Low Engagement NudgeMotivational Enhancements + SimplificationMotivational Enhancements + Simplification + GamificationMotivational Enhancements + Simplification + Gamification + Low Engagement NudgeMotivational Enhancements + Simplification + Low Engagement NudgeSimplificationSimplification + GamificationSimplification + Gamification + Low Engagement NudgeSimplification + Low Engagement Nudge

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 36-month-old child
  • ≥18-year-old parent
  • Internet access
  • willingness to commit to intervention/assessment procedures
  • proficiency in speaking and reading English

You may not qualify if:

  • child older than 36 months
  • parent younger than 18 years
  • no access to internet
  • not willing to commit to intervention/assessment procedures OR
  • not proficient with speaking and reading English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westat, Inc.

Rockville, Maryland, 20850, United States

Location

Study Officials

  • Kimberly Rhoades, Ph.D.

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Multiphase Optimization Strategy (MOST) factorial experiment. There are 4 experimental factors; each corresponds to the presence vs. absence of an engagement-focused intervention element. This experiment enables the estimation of the individual and combined effects of each element.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2022

First Posted

January 19, 2023

Study Start

September 16, 2023

Primary Completion

August 26, 2024

Study Completion

August 26, 2024

Last Updated

July 31, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations